FDA.reportPublic FDA data

Cathflo Activase

Product NDC
50242-041
11-digit product format
502420041
Labeler code
50242
Product ID
50242-041_0c2938dd-2978-411f-bd76-208fc8754838
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alteplase
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Genentech, Inc.
Application
BLA103172
Marketing category
BLA
Marketing start
2001-09-04
Substance
ALTEPLASE
Active strength
2.2 mg/2mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cathflo Activase
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALTEPLASE2.2 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1RXS4UE564

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-041-10Cathflo Activase2 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,218
50242-041-10Cathflo Activase10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1018
50242-041-64Cathflo Activase1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,118
50242-041-64Cathflo Activase2 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-041-10EA - Each50242-041e8ce1611-5211-4706-8a36-acee67fb608512019-11-12
50242-041-64EA - Each50242-041bf0baa6d-43ee-4799-b2fe-1a6209a9d87512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALTEPLASEACTIVE INGREDIENT1RXS4UE564CATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]3
ALTEPLASEACTIVE MOIETY1RXS4UE564CATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]3
ARGININEINACTIVE INGREDIENT94ZLA3W45FCATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]3
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-041CATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]15Current NDC, Legacy NDC, 4 package rows20241206_91ecdef2-95ff-42dd-a31c-c8a09cab3ad9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-041-105024200411010 VIAL in 1 CARTON (50242-041-10) / 2 mL in 1 VIAL10 vial2019-10-140000-00-00NoNoCurrent
50242-041-64502420041641 VIAL in 1 CARTON (50242-041-64) / 2 mL in 1 VIAL1 vial2001-09-040000-00-00NoNoCurrent